- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07693465
Impact of Spinal Alignment on Pelvic Floor Efficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pelvic floor dysfunction (PFD) may extend beyond the pelvic region by inducing myofascial disturbances in anatomically distant structures connected through the myofascial network. Among these, low back pain (LBP) is one of the most frequently reported musculoskeletal conditions associated with PFD. This relationship is thought to arise from lumbopelvic instability and altered coordination of the core musculature. The pelvic floor muscles (PFMs), together with the transversus abdominis, diaphragm, and multifidus, form an integrated stabilizing system that contributes to spinal stability and postural control. Consequently, dysfunction of the transversus abdominis may compromise not only pelvic floor function but also overall lumbopelvic stability. Women with LBP have been shown to exhibit reduced PFM contraction strength despite preserved transversus abdominis activation, suggesting that impaired PFM function may play a more prominent role in the development of LBP than deficits in the abdominal muscles alone. Conversely, inadequate activation or endurance of the transversus abdominis has also been associated with impaired PFM function. Furthermore, altered movement patterns, dysfunctional breathing, and postural deviations can disrupt load transfer through the lumbopelvic region, thereby increasing the risk of PFD.
There is a dearth of knowledge regarding the effect of spinal alignment on pelvic floor efficiency in nulliparous women. This study, therefore, contributes valuable insights into a relatively unexplored area of nulliparous women's health. By assessing the pelvic floor muscles in nulliparous women with different spinal alignment patterns, including lordosis, kyphosis, and scoliosis, this study may enhance the well-being of nulliparous women, provide a more comprehensive approach to health improvement, help protect them from future pelvic floor dysfunction, and broaden the scope of physiotherapy in women's health.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nulliparous women.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will not exceed 29.9 Kg/m2.
Exclusion Criteria:
- Female with congenital spinal deformity.
- Female with a history of neuromuscular disease.
- Female Diagnosed with any systemic disease .
- Female with a history of malignancy and/or ongoing treatment.
- Female with a history of urogenital diseases and surgical history.
- Female with previous spinal surgery.
- Female with previous pregnancy .
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nulliparous women with thoracolumbar scoliosis
Twenty nulliparous women with thoracolumbar scoliosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
|
No Intervention
|
|
Nulliparous women with hyperlordosis
Twenty nulliparous women with hyperlordosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
|
No Intervention
|
|
Nulliparous women with thoracic kyphosis
Twenty nulliparous women with thoracic kyphosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
|
No Intervention
|
|
Nulliparous women with normal spinal alignment
Twenty nulliparous women with normal spinal alignment.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle strength
Time Frame: Baseline
|
Pelvic floor muscle strength was measured using vaginal pressure biofeedback (maximum voluntary contraction pressure).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle endurance
Time Frame: Baseline
|
Pelvic floor muscle endurance was assessed using vaginal pressure biofeedback (duration of sustained maximal voluntary contraction).
|
Baseline
|
|
Spinal alignment angle
Time Frame: Baseline
|
It was measured using the DIERS Formetric 4D system.
|
Baseline
|
|
Pelvic floor dysfunction symptoms
Time Frame: Baseline
|
Total score and domain scores (bladder, bowel, prolapse, and sexual function) were assessed using the Australian Pelvic Floor Questionnaire (APFQ).
|
Baseline
|
|
Health-related quality of life
Time Frame: Baseline
|
It was assessed by using Free online SF-12 Health Survey Version 2 (SF-12v2) score calculator.
The SF-12V2 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Afaf Mohamed Mahmoud Botla, PhD, Professor, Cairo University
- Study Director: Amira Nagy Abd Ellatief Hamad, PhD, Lecturer, Cairo University
- Study Director: Amal Abd Elrahman Mohamed Elborady, Assist. Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005314
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.